The Effects of Nutritional Supplementation and Drug Abuse on HIV

Overview

The purpose of this trial is to determine whether supplementation with multivitamins and selenium will delay disease progression in HIV infected individuals in Botswana. The study will also assess how drug abuse modifies the effect of nutritional supplementation on HIV disease progression.

Full Title of Study: “HIV Disease, Drug Abuse, and Nutrient Therapy in Botswana”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2010

Detailed Description

Botswana has the highest rates of HIV infection in the world. In addition, drug abuse has become an emerging problem in Botswana. Past research suggests that multivitamin and selenium supplementation slows the progression of HIV disease. The purpose of this trial is to evaluate the effectiveness of supplementation with multivitamins and selenium in HIV infected individuals in Botswana. This trial will last 2 years. Participants will be randomly assigned to 4 groups: a combination of multivitamins with selenium, multivitamins alone, selenium alone, or placebo.

Interventions

  • Dietary Supplement: Multivitamins
    • dietary supplement of multivitamins
  • Dietary Supplement: Selenium
    • dietary supplement of selenium only
  • Other: Placebo
    • placebo pill

Arms, Groups and Cohorts

  • Placebo Comparator: 1
  • Experimental: 2
    • Multivitamins
  • Experimental: 3
    • Multivitamins with Selenium
  • Experimental: 4
    • Selenium

Clinical Trial Outcome Measures

Primary Measures

  • HIV Disease Progression
    • Time Frame: For at least 6 months

Secondary Measures

  • Morbidity
    • Time Frame: For at least 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • HIV infected – CD4 count greater than 350 cells/mm3 – Identified from the Infectious Disease Care Clinic – Body mass index greater than 18 for women and greater than 18.5 for men Exclusion Criteria:

  • Current AIDS-defining condition – Currently participating in another clinical trial – Pregnant or intends to become pregnant during the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Florida International University
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marianna K. Baum, PhD, Principal Investigator, Florida International University

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